Apparatus and method of non-invasive directional tissue treatment

ABSTRACT

An apparatus for non-invasive directional tissue treatment comprises an energy source and an array of energy delivery elements placed in a predetermined order defining a tissue treatment area such that tissue tightening obtained is higher in a first direction than in a second direction of the two-dimensional array.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/177,481, filed Nov. 1, 2018, which is a continuation of U.S. patentapplication Ser. No. 15/811,754, filed on Nov. 14, 2017, now U.S. Pat.No. 11,129,982, which is a continuation in part of International PatentApplication No. PCT/IL2016/050499 filed on May 11, 2016, which claimsthe benefit of U.S. Provisional Application No. 62/161,969, filed on May15, 2015, and U.S. Provisional Application No. 62/244,971, filed Oct.22, 2015; U.S. patent application Ser. No. 15/811,754 claims the benefitof U.S. Provisional Application No. 62/421,391, filed on Nov. 14, 2016,all of which are incorporated in their entirety herein by reference.

BACKGROUND OF THE INVENTION

The field of body contouring and tissue tightening has grown veryrapidly over the past several years, with many new devices appearing onthe market that utilize radiofrequency (RF) energy to safely andeffectively tighten and rejuvenate the skin.

For successful delivery and transfer of the RF energy into thermalenergy, different parameters must be considered including the size anddepth of the tissue being treated, as the tissue impedance of the tissuebeing treated affects the actual heat transfer. RF energy in the form ofelectrical current through the tissue can be designed to have differentheat impact and penetration depths in the tissue allowing for formationof different desired effects at different tissues at different desireddepth.

Different parameters are known to affect RF current passage via tissues,and the derived heat impacts in tissue. RF frequency, RF current leveland time duration, pulse mode including pulse modulation and inter-pulsedelay, distance between electrodes, level of electrodes protrusion tothe tissue and the like are among these influencing factors. The RFimpact derived from RF current flowing in and via tissue having electricimpedance, is being a tissue zone that is volumetrically heated to alevel of tissue stimulation, coagulation or ablation and theircombination.

Various RF bipolar configurations per-se or with the combination ofother modalities like ultrasound, vacuum apparatus, electro-opticalenergy and the like allow deeper RF current penetration under the skinthus addressing rhytids, sagginess concerns and vascular problems.

Multipolar (e.g. triple, 4, 5, 6, 7, 8 electrical poles) RF energyconfigurations are used in an attempt to continue to deliver enough RFenergy to be effective in skin rejuvenation and tissue tightening. Byusing multiple electrical poles, lower energies can be delivered intothe skin from each electrical pole, making the treatments superior tothe original monopolar. Multi-frequency RF energy devices to treatdifferent depths are also in use.

Fractional bipolar RF works as other fractional devices in a way thatthe targeted areas being treated are benefited from the vitality of theskipped (e.g. untreated) areas adjacent to the affected skin portions toheal the skin faster than traditional resurfacing methods. Thisconfiguration of fractional ablative RF was used to access deep into theskin, by applying high RF current density using very small diameterelectrodes and/or using protruded electrodes, to cause a rejuvenationresponse.

Monopolar RF configurations are also being used mainly for treatment ofdeep sub dermal layers. In these configurations the generated currentsflow through the tissue from one or more electrodes, all with the sameelectrical polarity to a grounding or “return” electrode, and meetsmaximum resistance in proximity the tip of the electrodes, where tissueheating in the deep dermal or sub dermal layers then occurs. Forexample, such a treatment may include the grounding or “return pad”attached to the patient's lower back or abdomen, to provide a lowresistance path for the current to flow back to the treatment generator,to complete the electrical circuit

The above products and treatment procedures commonly involve employingan applicator to house and translate the source of the applicationenergy over the skin, following various patterns of translation paths inan attempt to have a spatial uniform treatment over the treated zone ofthe skin. The resultant effect, mostly tightening, tends to behomogeneous in its nature. This is applied and has benefit when sameimpact is desired over the entire treatment area and such an impact isconducted in 3D (three dimensional) orientation, so impact has nodominated direction. This may be useful for instance for treatment ofearly stage skin ptosis, where the slight 3D tightening may besufficient to establish firmer and tighter look and feel of the skin.

At times it is desired to translate the source of the application energyover the skin, following various patterns of translation paths in anattempt to have a non-uniform spatial treatment, but rather a treatmentthat has a preferred orientation and/or a directional intensitydistribution. The resultant effect, for example tightening, is nothomogeneous and being applied more in certain direction as compared toother direction. This may have benefits when the application of higheror lower impact is desired in a directional treatment of an area. Thismay be useful, for instance, for treatment of advance stages of skinptosis of different body organs, where the directional impact of gravityon the organs may be of greater effect as compared to overallnon-directional loosening of tissue structure. Some medical conditionsthat may benefit from such treatment may be, for instance breast ptosis,facial droopy appearance, forehead wrinkles, loosened underarms and thelike. Occasionally, such directional impact may be required to fightother disorders, not of gravitation origin. This applies, for instancefor ageing effects on natural fold such as the facial nasolabial foldsor the marionette line folds having a desired dominated direction ofrequired tightening.

Directional tightening may be achieved by impacting the tissuenon-uniformly with significantly different heat distribution in onedirection as compared to the heat distribution in the other directions.This can be done in both micro and macro levels to result in ahomogenous or degraded directional tightening as will be describedherein.

As with all other tissues, time affects also breasts. Drooping orsagging female breast, manifest them as breast involution, withglandular volume loss, loose connective tissue support, extendedfascia-skin envelope and ligaments, and loss of elasticity. At thephenotype level ptosis is characterized by a downward (when female is inan upward sitting or standing position) descent of the nipple positiontogether with some descending of entire breast mass. Accordingly, theptosis scale of mild, moderate, advanced and severe ptosis representsthe location of the nipple relative to the infra-mammary fold.Pseudoptosis is when there is altered distribution of entire parenchymabreast mass, descending to the lower part of the breast with less to noimpact on nipple position.

Both ptosis and pseudoptosis may start already at the 20s and are anatural consequence of aging with prevalence of 100%. It is affected orinfluenced by intrinsic factors such as hormonal changes duringpregnancy and menopause leading to atrophies of glandular components,less cellular connective tissue and diminished collagen. Other intrinsicfactors that affect breast sagginess are Body Mass Index (BMI),overweight or weight loss, breast cup size and age. Ptosis andpseudoptosis are also affected by extrinsic factors, including exposureto the dreaded pull of gravity and smoking.

Breast ptosis and pseudoptosis for women, loose skin and saggingappearance of face, submental and chin, underarm, abdomen or buttocks ofboth genders are not a health issue but an aesthetic issue that mayadversely affects women's/men's self-image, confidence and self-esteem.It is therefore that efforts have been conducted for women and men ofwide range of ages to turn toward younger appearance and image.

Methods for changing the breast appearance toward younger look are basedon the basic anatomical fact that the breast is a “floating” organ, nothaving or not connected by muscles or any significant connective tissueor bones. Current methods for such rejuvenation of size, contour andposition of breasts sub anatomies such as nipples use invasive orminimal invasive modalities to reshape the breast pocket. It includessurgical procedures for breast lift or breast augmentation, invasiveimplant and positioning of threads, or minimal invasive RF derivedheating procedures. For the purpose of presentation of the previous artand the current invention, each right or left breast is schematicallydivided to upper and lower anatomical poles, each composed of twoquarters of the breast, for example, the lower anatomical pole includesthe lower left and the lower right quarters of a breast.

During common breast lift, mastopexy, surgeon make incision around theareola, then vertically down from the areola to the breast crease andhorizontally along the breast crease along the interface of the lowerbreast pole and the chest. Then excess breast skin is removed from thelower breast pole, the two edges of the skin cut are sutured, and theentire breast mass is positioned upward to compensate for its volumeloss and loss of elasticity. In addition to reshaping to improve contourand firmness, the nipple and areola may be repositioned to an upper,more youthful height. In general, mastopexy procedure raises, contours,and firms the entire breast by surgically impacting the lower pole ofthe breast.

Another method for breast lifting is by reshaping it using internalscaffold, mostly made of barbed/cogged threads. Surgeon makes 8-20trocars insertions into the subcutaneous fat layer, and each trocar istunneled along predetermined plane, having an exit point at its end. Thebarbed/cogged threads, designed to hook into the subcutaneous tissues,are inserted into the end of the trocar and pulled through it out of theopposite exit point. The trocar is then removed, and the thread isslightly pulled for reshaping of breast, tugged gently, hooked into thesubcutaneous tissue, stabilized and trimmed. Threads reconstruct thebreast shape and stimulate collagen synthesis around them.

Energy-based methods have also been conducted to treat breast ptosis.During such procedure. RF cannula with a tip that emits RF energy isinserted under the breast skin. The inserted cannula, which acts againsta second on-surface electrode, is run back and forth under the skinwhile emitting RF. During this process the emitted RF heats up thefibrous connective tissue of the breast fascia and dermis, locatedbetween the electrodes. When applied above a certain threshold, itcoagulates collagen and other extra-cellular matrices. This results incollagen shrinkage and collagen tightening and phenotype of 3D breasttightening and lifting.

The above techniques are invasive, and are associated with significantrisks—from anesthesia, bleeding or hematoma formation, infection, poorhealing of incisions, changes in breast or nipple sensation, breastcontour and shape irregularities or asymmetry, fat necrosis, fluidaccumulation, deep vein thrombosis, and the like. Additionally, peoplein general, are reluctant to go through invasive procedures when notmedically needed. Moreover, due to the invasiveness nature of thecurrent methods people with low grade ptosis, pseudo-ptosis or low gradeloosened skin don't tend to be treated to maintain a more youthfulappearance.

There is a need to improve the appearance of drooped or pseudo droopedbreast or loosened other anatomies using less traumatic and non-invasivemethods and modalities. Furthermore, due to the intimal nature of thetreatment it will be advantageous to do it at home comfort, usinghome-use-device (HUD).

SUMMARY OF THE INVENTION

Some embodiments of the invention may be related to an apparatus fornon-invasive directional tissue treatment. The apparatus may include: aradiofrequency (RF) generator and an array of RF energy deliveryelements in active communication with the RF generator, a power sourceand a controller. In some embodiments, each of the RF energy deliveryelements may include a pair of electrodes with opposite polarity orhaving a monopolar configuration such that each electrode may have afirst dimension and a second dimension, the first dimensionperpendicular to the second dimension and to an imaginary lineconnecting the pair of electrodes to each other. In some embodiments,the first dimension of each electrode and the distance between theelectrodes in each pair may be configured to create an elongated heatedvolume of tissue when the RF generator may be activated and at least oneof the RF delivery elements is in contact with the tissue.

Some additional embodiments of the invention may be related to a methodof non-invasive directional tissue treatment. The method may includesetting a treatment protocol and attaching at least a portion of anarray of RF emitting elements, powered by an RF generator, to an area ofthe tissue to be treated. The method may further include activating theRF generator and deactivating the RF generator by a controller, based onthe treatment protocol. In some embodiments, each of the RF energydelivery elements may include a pair of electrodes with oppositepolarity or having a monopolar configuration, such that each electrodemay have a first dimension and a second dimension, the first dimensionperpendicular to the second dimension and to an imaginary lineconnecting the pair of electrodes to each other. In some embodiments,the first dimension of each electrode and the distance between theelectrodes in each pair may be configured to create an elongated heatedvolume of tissue when the RF generator may be activated and at least oneof the RF delivery elements is in contact with the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter regarded as the invention is particularly pointed outand distinctly claimed in the concluding portion of the specification.The invention, however, both as to organization and method of operation,together with objects, features, and advantages thereof, may best beunderstood by reference to the following detailed description when readwith the accompanying drawings in which:

FIG. 1A is a schematic illustration of a radiofrequency (RF) deliveryelement according to one embodiment of the present invention;

FIG. 1B illustrates an array of RF delivery elements according to someembodiments of the present invention;

FIGS. 2A. 2B, 3A and 3B illustrate different configurations of RFdelivery elements according to embodiments of the present invention:

FIGS. 4A and 4B are schematic illustrations of layouts of arraysaccording to some embodiments of the present invention;

FIG. 5A is an illustration of arrays of RF energy delivery elementsaccording to some embodiments of the invention;

FIGS. 5B and 5C are illustrations of examples for tightening impact andparallel elongated bipolar pairs according to some embodiments of theinvention;

FIGS. 6A and 6B are illustrations of exemplary electrode configurationsaccording to some embodiments of the invention;

FIGS. 7A-7D are illustrations of additional exemplary electrodeconfigurations according to some embodiments of the invention;

FIG. 8 is an illustration of an array of RF delivery elements accordingto some embodiments of the invention;

FIG. 9 is an illustration of an array of RF delivery elements accordingto some embodiments of the invention;

FIGS. 10A and 10B illustrate 2D (two dimensional) arrays of RF deliveryelements according to some embodiments of the invention;

FIG. 11A is an illustration of an RF delivery element according to someembodiments of the invention;

FIG. 11B is an illustration of an array of RF delivery elementsaccording to some embodiments of the invention;

FIGS. 12A and 12B are illustrations of large arrays of RF energydelivery elements according to some embodiments of the invention;

FIG. 12C is an illustration of a directional RF bipolar pair and dual RFbipolar pairs according to some embodiments of the invention;

FIGS. 13A and 13B are an illustrations of arrays of RF delivery elementsaccording to some embodiments of the invention;

FIG. 14 is an illustration of an array of RF delivery elements accordingto some embodiments of the invention;

FIG. 15 is an illustration of a schematic operation method of an arrayof RF delivery elements according some embodiments of the invention;

FIG. 16 is an image of an electrode according to some embodiments of theinvention;

FIG. 17A is an illustration of an apparatus for non-invasive directionaltissue treatment according to some embodiments of the invention; and

FIG. 17B is a flowchart of a method of non-invasive directional tissuetreatment according to some embodiments of the invention;

FIG. 18A is an illustration of a pair of bipolar RF electrodes accordingto some embodiments of the invention;

FIGS. 18B-18C are heat intensity maps of treated tissues received from acomputer simulations according to some embodiments of the invention;

FIG. 19 is an illustration of desired tightening directions per breastpoles according to embodiments of the present invention;

FIGS. 20 and 20A illustrate an RF delivery elements array and wiringaccording to embodiments of the present invention;

FIGS. 21A and 21B is an illustrations of electrodes array and wiring forachieving a non-continuous tightening impact according to someembodiments of the invention;

FIGS. 22A and 22B are illustrations of moving applicators for achievingdesired impact in treatment in motion according to some embodiments ofthe invention;

FIG. 22C is an illustration of a stamping mode operation of theapplicator of FIG. 22B according to some embodiments of the invention;

FIGS. 23A-23C are illustrations of electrodes arrays to support severaltreatment directions according to some embodiments of the inventions;

FIGS. 24A and 24B are illustrations of electrodes arrays for supportingdifferent tissue thickness according to some embodiments of theinvention; and

FIG. 25 is an illustration of wearable applicator, designed as a bra,for achieving a desired impact according to some embodiments of theinvention.

It will be appreciated that for simplicity and clarity of illustration,elements shown in the figures have not necessarily been drawn to scale.For example, the dimensions of some of the elements may be exaggeratedrelative to other elements for clarity. Further, where consideredappropriate, reference numerals may be repeated among the figures toindicate corresponding or analogous elements.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

In the following detailed description, numerous specific details are setforth in order to provide a thorough understanding of the invention.However, it will be understood by those skilled in the art that thepresent invention may be practiced without these specific details. Inother instances, well-known methods, procedures, and components have notbeen described in detail so as not to obscure the present invention.

Although embodiments of the invention are not limited in this regard,discussions utilizing terms such as, for example, “processing,”“computing,” “calculating.” “determining,” “establishing”, “analyzing”,“checking”, or the like, may refer to operation(s) and/or process(es) ofa computer, a computing platform, a computing system, or otherelectronic computing device, that manipulates and/or transforms datarepresented as physical (e.g., electronic) quantities within thecomputer's registers and/or memories into other data similarlyrepresented as physical quantities within the computer's registersand/or memories or other information non-transitory storage medium thatmay store instructions to perform operations and/or processes. Althoughembodiments of the invention are not limited in this regard, the terms“plurality” and “a plurality” as used herein may include, for example,“multiple” or “two or more”. The terms “plurality” or “a plurality” maybe used throughout the specification to describe two or more components,devices, elements, units, parameters, or the like. The term set whenused herein may include one or more items. Unless explicitly stated, themethod embodiments described herein are not constrained to a particularorder or sequence. Additionally, some of the described methodembodiments or elements thereof can occur or be performedsimultaneously, at the same point in time, or concurrently.

Some embodiments of the present invention may provide method and device,using fractionally delivered RF to form directional impacts on thetissue, RF delivery elements and arrays for providing such directionalimpacts and image based diagnosis to affect treatment procedure of suchdirectional impact.

Embodiments of the present invention provide an apparatus and method fornon-invasive directional tissue treatment. The treatment may includedirectionally heating soft tissues to cause an impact on the tissue. Theimpact may include any effect of heating of soft tissue, for example,coagulation of collagen and other extra-cellular matrix, collagenshrinkage and phenotype of collagen tightening, tissue tightening andshrinkage, and the like. According to some embodiments, the method maybe based on fractional delivery of RF energy, using noninvasiveelectrodes embedded in tissue attachable patches/flex, while formingcontrollable (e.g., directional) treated volumes of tissue.

As used in this application, and in addition to its regular meaning, theterm ‘treated volume of tissue’ may refer to a portion of tissue heatedby one or more pairs of electrodes or heated by an elongated monopolarelectrode. The treated volume of tissue may have a first dimension thatmay be substantially equal to the inter-electrode spacing (i.e. thedistance between the electrodes in a pair of electrodes), a seconddimension and a third dimension (e.g. width and depth) that may derivefrom the dimensions of a face of an electrode directed towards the otherelectrode in a pair of electrodes or the dimensions of the elongatedmonopolar electrode. The depth of the treated volume of tissue may befurther affected from the inter-electrode spacing. In some embodiments,treated volume may be formed by applying RF current with predeterminedparameters between a pair of bipolar electrodes of a predeterminedconfiguration and inter-electrode spacing and each treatment volume maybe heated to levels of stimulation, coagulation, ablation and theircombinations.

The treated volumes may be of different dimensions, differentpredetermined orientations and inter-volume spacing, and may be formedat different tissue depth.

In some embodiments, assuming homogenous tissue and homogeneous heating,the impact on the tissue, such as tightening, may be directly correlatedwith the treated volumetric dimensions. Consequently, tissue tighteningmeasure may be substantially directly proportional to the treated volumedimensions. As a result, tightening measure of elongated treated volumesmay also have an elongated shape. Longer and narrower volumetric impactmay result in higher unidirectional absolute impact phenomena such astightening. The volumetric impact may be defined as the volume of thetissue that is impacted by the application of the RF energy by at leastone energy delivery element. The volume of the impacted tissue may belarger than the treated volume due to heat dissipation and othertightening effects discussed below.

In some embodiments, in order to achieve directional impact such astightening, the treated volumes and their distribution over the tissuemay be designed to have significant different dimension values (e.g.,impact dimension values) in one direction compared to another directions(e.g. orthogonal direction). This may be achieved both at the microlevel value (e.g., the dimension of a volume treated by a single pair ofRF electrodes) and in accumulated dimensions value of the overalltreated volumes at the macro level.

An apparatus according to some embodiments of the invention may include,a radiofrequency (RF) generator (illustrated and discussed with respectto FIG. 17A) and an array of RF energy delivery elements in activecommunication with the RF generator. Each of the RF energy deliveryelements may include a pair of electrodes with opposite polarity, toform the treated (impact) volume by applying RF energy to the electrodesand forming electric currents in the volume of a tissue treated by thepair of electrodes. In some embodiments, the array of RF energy deliveryelements may include a plurality of monopolar electrodes all being inelectrical connection with at least one current collector via thetissue. The volume of the tissue treated by the pair of electrodes orthe monopolar electrode may depend on the dimensions of the electrodes,the distance between the electrodes in the pair, and the like.

In some embodiments, each electrode may have a first dimension and asecond dimension, the first dimension perpendicular to the seconddimension and to an imaginary line connecting the pair of electrodes toeach other. In some embodiments, the first dimension of each electrodeand the distance between the electrodes in each pair may be configuredto create an elongated heated volume of the tissue when the RF generatoris activated and at least one of the RF delivery elements is in contactwith the tissue.

An exemplary energy delivery element 1 that includes a pair ofelectrodes is described in FIG. 1A. FIG. 1A is an illustration of anexemplary pair of electrodes 2 and 2 a having opposite polarity.Electrodes 2 and 2 a may have a length L and are placed in distance Wfrom each other, such that W is perpendicular to L. In some embodiments,delivery element 1 may include a single monopolar electrode 2 d(illustrated in FIG. 1B). A tissue treated (e.g., heated) volume 10 maybe dimensionally non-uniform, have significant different dimension indirection 11 (e.g. parallel to the distance W) as compared to direction12 (e.g. parallel to the width L). This form of treatment may result inan elongated treated volume of tissue. The aspect ratio W/L of the twodimensions may be >1 (larger than 1), for example, >2, >3, >4, >5 ormore.

An exemplary array of RF energy delivery elements is illustrated in FIG.1B. An array 5 may include a plurality of energy delivery elements 1placed in a predetermined order, for forming elongated heated volumes 10of the tissue when the RF generator (not illustrated) may be activatedand at least one of the RF delivery elements may be in contact with thetissue. The tissue in treated volumes 10 may be heated due to theapplication of RF energy via energy delivery elements 1, thus firmingthe tissue. In some embodiments, array 5 may include a plurality ofbipolar energy delivery elements each having electrode 2 and 2 a(illustrated in the top first rows in FIG. 1B) and/or may include aplurality of monopolar elements 2 d (illustrated in the bottom row inFIG. 1B).

As used herein all the disclosure discussing heated elongated volumescreated by applying RF currents via pairs of bipolar electrodes isapplicable also for elongated treated volumes created by applying RFcurrents via monopolar electrodes.

The treated volume shape, dimensions and depth may be affected by the RFelectrodes configuration, the RF energy parameters and tissueproperties, such as, heat dissipation and thermal relaxation timecharacteristics. For symmetric configuration of RF bipolar electrodes,the treated volume may have a symmetry line centered between theelectrodes and the treated volume may be adjusted to be centered inbetween the electrodes or to be separated into two zones adjacent to theelectrodes as will be described below.

FIGS. 2A-2B and FIGS. 3A and 3B are illustrations of some exemplaryenergy delivery elements according to some embodiments of the invention.In one exemplary embodiment, an RF delivery element 1 may includebipolar pair of electrodes 2 and 2 a of opposite polarity or a singlemonopolar electrode 2 d. Element 1 illustrated in FIG. 2A may include anelectrode length 30 (“L”) that may be significantly longer than thedistance 40 (“W”) between the electrodes. The volumetric tissue treatedvolume 10 may have elongated shape having its long axis parallel to theelectrodes long axis. As illustrated in FIG. 2A and FIG. 2B, the closerthe electrodes are to each other, the smaller the inter-electrodedistance W is, and a higher length L to distance W ratio of treatedvolumes 10 may be reached. In FIG. 2B the inter-electrode distance W islarger than the distance W in FIG. 2A, while the length L is maintained,and consequently the length L to distance W ratio is lower than in FIG.2A. According to some embodiments, the ratio L/W may be >1 (larger than1), for example, larger than 2, 3, 4, 5 or more. Assuming the same RFfrequency, the treated volumes may be shallower for closer electrodes,such as the electrodes of FIG. 2A and deeper for more distantelectrodes, such as the electrodes illustrated in FIG. 2B. As thedistance W between the electrodes increases, a set of RF parameters canproduce two separated elongated treated volumes, each elongated treatedvolume close to one of the electrodes as described herein with referenceto FIG. 18D.

FIG. 18A is an illustration of a pair of bipolar RF electrodes 2 and 2 aor a single monopolar electrode 2 d that creates elongated treatedvolume 10. Cross section AA′ may be transverse to the longitudinaldimension of electrodes 2 and 2 a or a single monopolar electrode 2 dand cross section BB′ may be parallel to the longitudinal dimension ofelectrodes 2 and 2 a. FIGS. 18B, 18C and 18D present simulation resultsof a heat impact profile in treated volume 10 of tissue 80 havingexposed skin portion 85, post RF delivery between electrodes 2 and 2 aor between a single monopolar electrode 2 d and a current collectingelectrode, according to embodiment of the invention. FIG. 18B is a viewof the cross section along BB′ and FIG. 18C is a view of the crosssection along AA′ of the heat profile of treated volume 10 in aconfiguration where the electrodes are in close proximity. The crosssections may describe an elongated treated volume 10 having high ratiobetween the orthogonal dimensions (e.g. length L, and width W) oftreated volume 10. FIG. 18D presents a cross sectional view along lineAA′ of the heat profile of treated volume 10 for the setup described inFIG. 18a having increased distance between the electrodes 2 and 2 a orincrease the elongated dimension of monopolar electrode 2 d andincreased electrodes protrusion. As used herein electrodes protrusion isdefined as the depth that electrodes 2 and 2 a or a single monopolarelectrode 2 d are being pushed into exposed skin portion 85. Due to thelarger distance between the electrodes (e.g., the distance is largerthan the heat dissipation distance for a particular set of RF energydelivery parameters (power, frequency, time, etc.), in thisconfiguration the impact may be formed as a separated two sub-volumes10, each sub-volume 10 in relative proximity to one of electrodes 2 and2 a or a single monopolar electrode 2 d.

In another exemplary embodiment, illustrated in FIGS. 3A-3B, for each RFenergy delivery element 1 having bipolar pair of electrodes 2 and 2 a,an electrode length L may be significantly shorter than the distancebetween the electrodes W. In yet another exemplary embodiment, for eachRF energy delivery element 1 having a single monopolar electrode 2 d, anelectrode length L may be significantly shorter than the electrode widthW. The treated volume 10 may have elongated shape having a longitudinaldimension parallel and substantially equal to the distance W between theelectrodes. As seen in FIG. 3B, for a given electrode length Lsignificantly shorter than the inter-electrode distance W, the largerthe inter-electrode distance W is, treated volume 10 may have a moreelongated shape. The ratio between electrode length L andinter-electrode distance W, L/W may be <1 (smaller than 1), <0.5, <0.33,<0.25 or less.

Referring to FIGS. 4A and 4B that are illustrations of exemplary arrays5 of energy delivery elements (I in FIGS. 1A, 2A, 2B. 3A and 3B)according to some embodiments of the invention. Each of RF energydelivery elements in each array 5 may be in active communication with anRF generator (not illustrated) and with a power source and a controller(also not illustrated). Arrays 5 may be designed to directionallytighten an area of tissue. In FIG. 4A arrays 5 may include RF bipolarelectrode's pairs (RF energy delivery elements 1) or a plurality ofmonopolar electrodes 2 d that may be placed over the treated area. Inorder to achieve directional tightening, the treated volumes 10 of eachpair and their distribution over the tissue may be designed to havesignificant different dimension in direction 31 compared to anotherdirection 32 both in micro level such that the distance between theelectrodes

is larger than the length of the electrode

>>

and as accumulated dimensions of the overall treated volumes in macrolevel, such that W>>L and the resulted impact may be higher alongdirection 31 as compared to direction 32. A similar effect may beachieved using electrode having a distance between the electrodes

smaller than the length of the electrode

so that

>>

, as illustrated in FIG. 4B. The accumulated dimensions of the overalltreated volumes in a macro level, may be such that L>>W and the resultedimpact may be higher along direction 31 as compared to direction 32.

Referring to FIG. 5A an illustration of an array of RF energy deliveryelements according to some embodiments of the invention and acorresponding graph showing heat contributions in the tissue are shown

FIG. 5A shows an array of RF energy delivery elements configurationwhere a distance 17 between electrode pairs or the monopolar electrodesmay be smaller than the heat dissipation distance per a treatment timeperiod. The heat dissipation of the electrodes pairs is illustrated ingraph 50 of FIG. 5A and may be a function of the electrodes and pairgeometry configurations, the area or volume that is treated by applyingRF energy (treated volume 10) by each pair of electrodes, the heatconduction properties of the treated tissue, and the like. Each pair ofelectrodes or the monopolar electrode contributes heat that dissipatesmainly in the corresponding treated volume. However, some of the createdheat may dissipate from the treated volumes into the volume of tissuebetween pairs of electrodes in an array, also referred to as distance orgap 17. The heat distribution contributed by each pair the monopolarelectrode is illustrated in graph 50 of FIG. 5A. Graph 60 is anillustration of the accumulated heat distribution from all the pairs. Insome embodiments, not only the treated volumes 10 between the electrodesare heated to the impact level but also the volumes of tissue in gaps 17between heated volumes 10 are heated to the impact level due to theaccumulation of dissipated heat and the consequent loss of fractionalimpact.

In some embodiments, when gap 17 between heated volumes 10 is largerthan the heat dissipation distance per time of each heated volume 10,then the inter pairs the monopolar electrode volumes of gap 17 may notbe heated to the level desired to produce impact (for example,tightening). This may enable keeping fractional directional effect andmay prevent bulk heating while the combined effect may be a combinationof separated treated volumes. In this case the tissue in the volumespaces of gap 17 between the treated (e.g., heated) volumes 10 may beaffected not by direct heat but by other biological or physicalmechanisms. An example for the effect of biological or physicalmechanisms, such as tightening impact, formed by an array of parallelelongated bipolar pairs is illustrated in FIGS. 5B and 5C. Tissue 8 maybe heated by an array of RF bipolar electrodes 9. Treated volumes 10 maybe tightened by some percentage of their dimensions TP (TighteningPercentage) due to the derived heating.

In some embodiments, an accumulated elongated treated volume 173,illustrated in FIGS. 5B and 5C may include the sum of adjacent treatedvolumes 10 along a direction 73. In FIG. 5B, for each of accumulatedelongated treated volume 173 the tightening of the tissue alongdirection 73 may be substantially equal to the tightening percentage,multiplied by the accumulated width

(e.g., the distance between the electrodes) of treated volumes 10 alongdirection 73. The tightening of the tissue of accumulated elongatedtreated volume 173 in direction 75 transverse to direction 73 may besubstantially equal to the tightening percentage, multiplied by thelength

of heated volumes 10 (e.g., the length of the electrodes) alongdirection 75. These tissue tightening values may be given by equations(1) and (2):

T _(W) =TP*Σ

  (1)

T _(L) =TP*

  (2)

In FIG. 5C for each elongated treated volume 173 the tightening of thetissue along direction 73 may be substantially equal to the tighteningpercentage, multiplied by the accumulated length

of heated volumes 10 (e.g. the electrodes length) and tightening ofelongated treated volume 173 in direction 75 may be substantially equalto the tightening percentage, multiplied by the width

The tissue tightening values may be given by equation (3) and (4):

T _(L) =TP*Σ

  (3)

T _(W) =TP*

  (2)

Gaps 17 between heated volumes 10 that may have not been heated to alevel that may cause tightening, may undergo elastic and sheer forcesdue to the shrinkage of adjacent treated volumes 10. These forces maypull tissue 8 in these volume gaps 17 and may cause a reduced level oftightening compared to the tightening level of treated volumes 10. Thetightening of gaps 17 may be dependent on: the dimensions of treatedvolumes 10 (i.e.,

and

) and gaps 17, on the shrinkage levels of treated volumes 10 (e.g., TP),on the tissue's mechanical characteristics and/or on the temperature inthe tissue between heated volumes 10 which may be dependent on the heatdissipation from treated volumes 10. Other parameters may affect thetightening effect at gaps 17. The tightening along directions 74 alonggaps 17 between treated (e.g., heated) volumes 10, may be given byequation (3), for array 9 of FIG. 5B:

Tightening between treated volumes:

T ₇₄=[TP*Σ

]*CTF(D,T(HD),M(T))  (5)

where:

CTF=Tissue Coupled Tightening Factor

D=Distance between electrode lines (e.g., gap 17)T(HD)=Tissue Temperature which is dependent on the heat dissipationM (T)=Tissue mechanical parameters that are temperature dependent. Theimpact intensity and the treated volume shape, dimensions and locationbetween the electrodes may be affected and controlled by a combinationof parameters including: electrode configuration and spacing, electrodeprotrusion into the tissue, the tissue heated temperature profile overtime, the RF current parameters, such as frequency, pulse profile, pulsemodulation, intensity and duration, heat dissipation characteristics,thermal relaxation time of the particular treated tissue and coolingprofile of the electrodes and the tissue surface properties.

FIGS. 6A-6B are illustrations of exemplary embodiments, in whichdifferent electrode configurations are used to set elongated volumetrictreated (e.g., heated) volume 10 having distance

between the electrodes and length

of the electrodes). In FIG. 6B a set (e.g., an array) of elongated RFbipolar pairs (e.g., RF energy delivery elements 1) or monopolarelongated electrodes may be placed to form a plurality of heated volumes10. The RF energy delivery elements are such that the longitudinaldimensions of treated volumes 10 are substantially parallel to length

of electrode with inter RF energy delivery elements gap 17 larger thanthe heat dissipation distance of each delivery element. In FIG. 6A a setof shorter RF pairs or shorter monopolar electrode (e.g., RF energydelivery elements 1) with larger inter-electrode distance

may be placed to form heated volumes 10 similar to those illustrated inFIG. 6B. The combined tightening at the overall treated area may be acombined effect of all elongated heated volumes 10 and may be given byEquations 6.

6) for the array of FIG. 6A

T _(L) =TP*Σ

  6.1)

T _(W) =TP*w  6.2)

for the array of FIG. 6B

T _(L) =TP*

  6.3)

T _(W) =TP*Σw  6.4)

FIGS. 7A to 7D are illustrations of additional exemplary electrodeconfigurations according to some embodiments of the invention. A set(e.g., an array) of elongated bipolar pairs or elongated monopolarelectrode (e.g., RF energy delivery elements 1) are placed posterior toeach other, along the same longitudinal direction. In FIGS. 7A and 7Bthe configuration may be set to prevent spacing between treated (e.g.,heated) volumes 10. As illustrated in FIG. 7A, in some embodiments, eachenergy delivery element 1 may have at least one electrode 2′ that iscommon to a proximal energy delivery element 1′ to create a continuouselongated treated volume 10′. According to an embodiment, as illustratedin FIG. 7B as each energy delivery element 1 is tangent to at least oneproximal energy delivery element 1 treated volumes 10 are tangent toeach other, to create a continuous cumulative treated volume 10′.

As may be seen in FIGS. 7C and 7D, according to some embodiments,treated volumes 10 may be spaced apart to form gap 18 (between every twoproximal RF delivery elements at the same row). According to someembodiments, gap 18 may be larger than the heat dissipation distance.The combined tightening at the overall treated area may be a combinedeffect of all elongated heated volumes 10 and may be given by Equations7:

7) for the array of FIG. 7C

T _(L) =TP*

  7.1)

T _(W) =TP*Σw  7.2)

for the array of FIGS. 7D

T _(L) =TP*Σ

  7.3)

T _(W) =Tp*w  7.4)

In yet another exemplary embodiment a plurality of elongated RF bipolarpairs or a plurality of monopolar electrodes (e.g., RF energy deliveryelements 1) may be placed in a 2D array as illustrated in FIG. 8. Ineach row the elongated pairs may be placed such that an electrode 2 ofelement 1 is close to an electrode 2 of element 1′, along the samedirection, as to form gap 18 between two RF delivery elements at thesame row. According to some embodiments, gap 18 may be larger than theheat dissipation distance. At least two rows may be placed parallel toeach other as to form inter row distance 17. According to someembodiments, inter-row distance or gap 17 may be larger than the heatdissipation distance. Overall, the dimensions of distances 17 and 18 perthis embodiment may be configured to enable discrete non-continuousfractional treated volumes 10 (i.e., as oppose to the embodimentsdisclosed in FIGS. 7A and 7B). Additionally, the sum of longitudinaldimension of treated volumes 10 across the rows Σ

is significantly smaller than the sum of the treated dimensions alongthe rows Σ

as given in Equations 8.

T _(L) =TP*Σ

  8.1)

T _(W) =TP*Σw  8.2)

T _(L) <<T _(W)  8.3)

In yet another exemplary embodiment illustrated in FIG. 9, a pluralityof elongated treated volume 10 formed by RF delivery elements 1 placedin a 2D array. Each two adjacent RF delivery elements 110, 120 may shareone electrode having a first polarity 130 while the other electrodes130′ of elements 110 and 120 may have a second polarity opposite to thefirst polarity. In some embodiments, delivery elements 110, 120 may havea monopolar configuration having a plurality of elongated monopolarelectrodes 135 all having the same polarity and the currents applied bythese electrodes are all collected by at least one collector to “return”electrode (not illustrated). At least two rows may be placed parallel toeach other but may be shifted along the rows direction in such a waythat treated volumes 10 placed in a first row may be indented withrespect to treated volumes 10 placed in a second row forming a volume100 between treated volumes 10 of the other row and vice versa. Theinter row distance (i.e., the width of volume 100) may be larger thanthe heat dissipation distance. Additionally, the sum of heated volumealong the rows may be significantly larger than the sum of the heatedvolume across the rows as given by Equations 9.

T _(L) =TP*Σ

  9.1)

T _(W) =TP*Σw  9.2)

T _(L) <<T _(W)  9.3)

In accordance with another exemplary embodiment of the currentinvention, illustrated in FIGS. 10A and 10B, a plurality of elongatedbipolar pairs or monopolar electrodes (e.g., RF energy delivery elements1) are placed in a 2D array. A first and second sets of elongated RFbipolar pairs may be placed such that an electrode 2 of element 1 isclose to an electrode 2 of element 1′, along a curved line, with intercurved line gap 17 larger than the heat dissipation distance pertreatment time. At least two sets each placed in a curved line or arcmay be placed such that a constant distance (gap 17) is kept along theradii of the cured lines. The first and second sets may be shifted alongthe curved line direction in such a way that treated volumes 10 of thefirst row may indented with respect to the treated volumes 10 of thesecond row. Inter curved-line distance 17 may be larger than the heatdissipation distance. Additionally, according to some embodiments, thesum of inter electrode distances w (as illustrated in FIG. 1A) may bemuch longer than the length of the electrodes L (as illustrated in FIG.1A), in the array of FIG. 10A and vice versa in the array of FIG. 10B.This configuration may cause directional tightening along the curvedlines. According to some embodiments, an array as illustrated in FIGS.10A and 10B may be adapted to provide directional tightening along acurved line, for example, for treating anatomies like periorbitalcrow-feet wrinkles and the like.

Another exemplary embodiment is shown in FIGS. 11A-11B. A plurality ofRF energy delivery element (e.g., a bipolar set of electrodes)illustrated in FIG. 11A are placed in a 2D array illustrated in FIG.11B. The volumetric impact created by each electrode's pair hassubstantially same dimensions in so dimensions L and W are substantiallyequal. The density of pairs (also referred to as the spacing betweenpairs) along a first direction 31 is higher than the density of pairs inthe second direction 32 (orthogonal to direction 31) such that thespacing between the pairs are shorter. The density may be defined as thenumber of RF delivery elements located at a specific area (within thearray). This may result in a difference in the sum of length of treatedvolumes per area along direction 31 compared to the sum of length oftreated volumes per area along the orthogonal direction 32. Therefore,directional impact, for instance directional tightening, may be producedalong direction 31. Directional impacts according to some embodiments ofthe invention may form when the elongated treated volumes (or theelongated accumulated treated volume) may cause substantially differentamount of tightening of the tissue in the longitudinal and transversedimensions of the treated volumes. Accordingly, the amount tightening ofthe tissue in the longitudinal dimension may be substantially higher(e.g., at least 2 time higher) than the amount of tightening in thetransvers dimension, causing a directional tightening or a directionalimpact.

In some embodiments, method and device of the invention may beconfigured to enable homogeneous directional impact per accumulatedaffected zone. In accordance with exemplary embodiments of the currentinvention, electrode pairs (RF delivery elements) may be homogeneouslyspread in the electrodes array (e.g., patch) placed over a treated area.FIGS. 12A and 12B are illustrations of arrays of RF energy deliveryelements (having a plurality of pairs of bipolar electrodes or aplurality of monopolar electrodes). Each point in the drawingsrepresents an RF delivery element 1 that includes bipolar electrodes 2and 2 a a monopolar electrode 2 d, or dual bipolar electrodes 2 b and 2c and treated volume 10 as illustrated in FIG. 12C. Such homogeneousspreading, may include fixed electrode pairs density, inter-electrodedistance, and inter-pairs distance that may be kept essentially constantin the entire treatment (e.g., tightening) process as illustrated inFIG. 12A. According to some embodiments, as illustrated in FIG. 12B, theRF elements may be randomly placed to form randomly located elongateddirectional impacts. Each point in FIG. 12B represents a directional RFbipolar pair, a monopolar elongated electrode or dual RF bipolar pairsas illustrated in FIG. 12C. All the elongated directional RF pairs maybe oriented to the same direction. Homogeneous directional impact may beapplied, for example, for forehead skin tightening.

In some embodiments, method and device of the invention may beconfigured to produce directional, degraded impact having variableimpact intensity along at least one predefined direction. In someembodiments, the density of the RF delivery elements may vary within thearray. In some embodiments, the array may comprise at least a firstgroup of RF energy delivery elements located at a first area and asecond group of RF delivery elements located at a second area differentfrom the first such that a density of the RF energy delivery elements inthe first area may be different from a density of the RF energy deliveryelements in the second area.

In some embodiments, a distance between two neighboring RF deliveryelements in any direction (e.g., inside the rows or between the rows)may be changed along a desired direction, forming a changing density ofthe RF delivery elements. For example, a first distance between firstand second RF delivery elements may be different from a second distancebetween the second and third RF delivery elements, in the array of RFdelivery elements. In some embodiments, the first distance may be largerthan the second distance and the second distance may be larger than athird distance between the third and a forth RF delivery elements, as toform a degrading heating effect. Such an exemplary arrangement isillustrated in FIG. 13A.

Referring to FIG. 13A, that is an illustration of an array of RF bipolarpairs or an array of monopolar electrodes (e.g., RF energy deliveryelements) all having same inter-electrode spacing W or width W, may bearranged in columns, the columns may substantially be equally spaced. Insome embodiments, the columns spacing D may start to increase alongdirection 300, such that consequently the level of impact may graduallydecrease. As can be seen in FIG. 13A, according to some embodimentsD₁<D_(n)<D_(n+1) however. W₁=W_(n)=W_(n+1).

In some embodiments, the same effect may be received by changing theinter-electrode spacing W or the length W of the monopolar electrode. Insome embodiments, a first distance between the electrodes in a firstpair may be different from a second distance between the electrodes in asecond pair. In some embodiments, the first distance between theelectrodes in the first pair may be smaller than the second distancebetween the electrodes in the second pair and the second distancebetween the electrodes in the second pair may be smaller than a thirddistance between the electrodes in a third pair. Referring to FIG. 13Billustrating another exemplary array of RF elements (e.g., bipolar pairsor monopolar electrodes) in which the impact degradation may be producedby degraded inter-coupled electrode distance W of the pairs along adesired direction to produce gradually shallower heating effect whilekeeping the inter-pair distance D equal. As seen in FIG. 13B, accordingto some embodiments, the distance W₁>W_(n)>W_(n+1) whileD₁=D_(n)=D_(n+1). The two described approaches of FIG. 13A and FIG. 13Bcan be combined for a specific need. In some embodiments, degradedimpact may be desired and applied, for example, for treatment of thenasolabial fold, where higher tightening impact is needed in closeproximity to the fold, and lower tightening intensity, of same directionis needed, the closer we get to the ear.

In some embodiments, a single array of RF delivery elementsconfiguration may support both homogeneous directional impact andnonhomogeneous degraded impact, using different RF parameters fordifferent electrode pairs or different monopolar electrodes in thearray. For homogeneous effect, the RF parameters may be defined per pairor monopolar electrode to compensate for lack of homogeneity of theelectrode configuration so to adjust tissue impact per predeterminedzone for homogeneity purposes. Similarly, tuning of the RF parametersper pair or monopolar electrode may be used to produce nonhomogeneouseffect, for example, by increasing or reducing RF parameters along apredetermined direction to produce gradual impact, as illustrated inFIG. 14. FIG. 14 is an illustration of an exemplary array of RF deliveryelements according to some embodiments of the invention. In the array ofRF bipolar pairs or monopolar electrodes of FIG. 14 both the interelectrode spacing W or length of the monopolar electrode and the interpairs spacing D may be substantially equal between all the pairs. Forsome of the pairs or monopolar electrodes the RF parameters are equal toproduce equal directional impact I₁ while at some point the RFparameters may be changed to produce gradually decreased Impact I₂(x)along direction 300. The decreased impact may be related, for example,to reduce coagulation level, or for producing lower phenotype yieldedimpact, for example, stimulation instead of coagulation alongpredetermined direction(s). It should be appreciated that graduallyincreased impact may be achieved in a similar manner.

In some embodiments, similar effects may also be established byalteration of treatment regime, including number of treatments andinter-treatment intervals, per treated zones and subzones. The finaldesired directional impact may be established by any combination of theabove and may be controlled by a controller of the system based onanatomy and tissue characteristics like thickness, degree of ptosis,local impedance and the like.

FIG. 15 is an illustration of a schematic operation method of an arrayof RF delivery elements according to some embodiments of the invention.Array 140 comprising a plurality of RF delivery elements may be operatedsuch that only a sub-set 150 of the plurality of elements in array 140is operated at the same time while all other RF delivery elements do notdeliver RF energy. Array 140 may be divided into several (e.g., 4, 6, 8or any other number of subsets) subsets of the bipolar pairs ormonopolar electrodes. The sub-sets may be operated sequentially (in FIG.15 the currently operating elements in each array are illustrated asblack short lines in comparison to the grey lines that representnon-operating RF elements), with or without time delay. Since onlysubset 150 of array 140 is being operated per given time period, only aportion of the tissue that is in contact with activated sub-set 150 isbeing fractionally heated each time as illustrated in FIGS. 15 A-F. Thismay result in reduced heat sensation, enhanced convenience andcompliance of the user. Additionally this mode of operation may requirelower power source, as compared to concomitant activation of the entirearray 140, and thus may be appropriate for home care treatments. Theoperated subset may include any number of pairs or monopolar electrodes(RF delivery elements 1), adjacent, separated or randomly selected, andthe operation sequence of the subsets can be of any spatial and timesequence as desired by the treatment protocol.

As used herein, a treatment protocol may include selected parameters forthe operation of an apparatus for non-invasive directional tissuetreatment for a specific treatment. The protocol may include RF deliveryparameters such as the RF frequency and the RF power in which the RFenergy is to be delivered in the specific treatment. The protocol mayfurther include the timing and the duration (e.g., pulses, continuous,etc.) in which the RF energy is to be delivered and the number andlocation of the RF delivery element (e.g., a sub-set from the pluralityof RF delivery element) to which the RF energy is to be delivered. Thetreatment protocol may be determined by a user (e.g., a professional),by the apparatus (e.g., based on parameters of the patient uploaded intoa controller associated with the apparatus) or a combination of both.

The protocol may include online monitoring and feedback of the actualtreatment. This may be conducted using assisting agents, such assmartphone, and dedicated software application to control the entireprocedure. Post medical evaluation to ensure applicability, there may bedetermination of a size of the tissue or organ to be treated andrequired tightening level to confirm the suitability for the procedure.Thereafter, the skin (dermis and fascia) thickness may be determinedusing an apparatus according to an embodiment of the invention. With theadditional skin thickness data measured with the apparatus, thetreatment protocol and treatment parameters per area may be defined. Anexemplary protocol may include three levels: I) a determination of RFparameters for a single delivery of RF energy to a specific area (e.g.,RF power, pulse sequencing, direction, depth, number of RF cycles toenable comfort use), II) a session procedure (for instance, an amount ofenergy that may be delivered to achieve a desired impact per day,sequencing between areas etc.), and III) an overall cycle of treatmentsessions (for instance, a number of overall treatments, their dailytiming, or the like). This may differ in some terms between a stationaryand a moving applicator (illustrated in FIGS. 22 and 25).

In some embodiments, during an actual treatment, the apparatus (e.g.,apparatus 70, 200 or 250) may be configured to detect the skin thicknessand its initial temperature. Post ensuring conductivity by test pulses,system may be activated to deliver fractional treatment RF energy to apredetermined depth, using appropriate RF parameters. Temperature may becontinuously measured (e.g., by temperature sensors and/or by low leveltissue impedance sensing pulses) and used as control feedback forcontrolling the RF energy delivery parameters of the apparatus. At eachtreatment end the skin thickness may also be determined.

In one embodiment, the treatment results at end of treatment, as well asjust before the next treatment may be used to adjust the treatmentprotocol, in case the improvement achieved is not as plan. According tonon-limiting embodiment this may be conducted using the smartphoneapplication. The latter may also be used to schedule and alerttreatments as well as for post treatment cycle maintenance session formaintaining the results of the treatment sessions.

In accordance with another exemplary embodiment the RF electrodes' shapemay be designed to reduce the RF current density at the electrode'ssurface which is directed towards the other electrode in a pair ofelectrodes (for example, the pair in RF delivery element 1 illustratedin FIG. 1A). The reduction of the current density may assist preventingoverheating and hotspots at the treated tissue adjacent to theelectrodes and may further reduce and even eliminate the need for tissuesurface cooling. The electrodes may have rectangular rounded cornershape and a sub mm or mm thickness that may be pushed, during treatment,towards and deform the skin surface with its rounded corners and facets.Such an exemplary electrode shape is illustrated in FIGS. 16A and 16Bwhich show a perspective view and top view (respectively) of anelectrode according to one embodiment of the present invention. Inaccordance with yet another exemplary embodiment of the invention RFdelivery parameters, such as frequency, pulse mode, modulation ifpulsed, intensity and duration may be determined to form volumetriceffect that takes into account the heat dissipation characteristics ofthe particular treated tissue to maintain the fractional nature oftissue impact and the overall elongated profile of the effect. The heatdissipation characteristics, the electrodes dissipation characteristicsand the combination with RF current modulation and other RF parametersmay be used for dissipating the heat at the electrodes contact area withthe skin. Dissipating the heat may eliminate hot spot and may controlthe dissipation of heat outside of the treated area as to maintainelongated impact. According to some embodiments, other element, such as,cooling elements (not shown) may be used to assist in maintaining thevolumetric elongated impact.

Referring to FIG. 17A, an apparatus for non-invasive directional tissuetreatment according to some embodiments of the invention is shown. Anapparatus 70 may include an array 205 of RF delivery elements 210. Array205 may be any array of RF delivery elements according to any embodimentof the invention. When array 205 include monopolar electrodes apparatus70 may further include a grounding or return (current collector) pad orelectrodes 240. In some embodiments, grounding or return pad orelectrodes 240 may be included in array 205.

Apparatus 70 may further include a radiofrequency (RF) generator 310, apower source 320 and a controller 360. In some embodiments, controller360 may be in active communication with an image processing device 350and an imager 355. Imager 355 may be any device for capturing images oftissues known in the art. Imager 355 may be a camera, an ultrasounddevice, a CT device, an X-ray device. MRI device or the like. In someembodiments, apparatus 70 may further include one or more sensors 230,and controller 360 may include a timer and a time control unitconfigured to automatically monitor and control employment of theapparatus (e.g., timing and duration of the heat treatment).

Array 205 may include a plurality of RF delivery elements 210 such thateach of the RF energy delivery elements may include a pair of electrodes(e.g., electrodes 2, 2 a, 2 b or 2 c illustrated in FIGS. 1-3 and 12C)with opposite polarity or monopolar electrodes 2 d illustrated in FIG.1B as disclosed herein. Each electrode in element 210 may have a firstdimension and a second dimension, the first dimension perpendicular tothe second dimension and to an imaginary line connecting the pair ofelectrodes to each other. Furthermore, the first dimension of eachelectrode (either bipolar or monopolar) (e.g., L illustrated in FIGS.1-3) in element 210 and the distance between the electrodes (e.g., Willustrated in FIGS. 1-3) in each pair may be configured to create anelongated treated volume of tissue (e.g., volume 10 illustrated in FIGS.1-3) when RF generator 310 may be activated and at least one of the RFdelivery elements may be in contact with the tissue. Apparatus 70 mayfurther include a cooling unit (not illustrated) to reduce theelectrodes and/or the treated tissue temperature.

Apparatus 70 may further include at least one temperature sensor 230, anRFID sensor 220, or any other suitable sensor that may be monitored bycontroller 360 to control the RF parameters applied to array 205. Insome embodiments, array 205 may be included in a consumable ordisposable patch. Additional sensing and controlling may be done basedon sensing the tissue impedance by applying low current (e.g.,monitoring current) via element 210 or by a specific sensor to monitorthe tissue temperature and to use these measurements to assess theamount of RF energy (and RF parameters) required for achieving a levelof impact (e.g., directional tightening) of the treated tissue.

According to some embodiments, a flexible plate (e.g. a patch) mayinclude an electrode array (an array of RF delivery elements) that maybe: embedded in an attachable flexible plate; 3D printed into anattachable flexible plate, or may be an integral part of tissueattachable flexible plate. The flexible plate may be designed to havedielectric characteristics that differ from the conductivitycharacteristics of the electrodes. The flexible plate may also beconfigured to easily and comfortably be placed, fit and/or attached toanatomies of different morphologies. It may be formed of flexibledielectric materials such as silicone, silicone gel, fabric, flexibleprinted circuit board and any other form or material known in the art.The flexible plate may be covered with adhesive layer for good adherenceto the skin, as well as for enhanced electrical coupling of theelectrical current between the electrodes and the affected skin. Theadhesive layer may for instance be in form of gel, glue or double sidedadhesive sheet and may be an integral part of the flexible plate (alsoreferred to as flex), or placed over flex or over skin before treatment.

According to some embodiments. RF generator 310 may be configured tosupply RF energy to RF delivery elements at various RF deliveryparameters. The RF delivery parameters may include, the RFfrequency(ies), RF power levels, or the like. For example, the RF energygenerated by the RF generator may be in the range of 50 kHz-10 MHz or inthe range of 500 kHz-3 MHz. In some embodiments, the power supplied bypower source 320 may be in the range of 1-100 Watt.

Other RF energy delivery parameters may include: timing of the RF energyapplication, the duration of the RF energy application and a selectionof a sub-set of RF energy delivery elements from the plurality ofelements in the array for delivering the RF energy to the tissue and aparticular timing of the delivery. In some embodiments. RF generator 310may be configured to generate pulses of RF energy according toinstructions received from controller 360, based on a treatmentprotocol. For example, each RF pulse′ duration may last between 50milliseconds and 60 seconds.

In accordance with yet another exemplary embodiment of the currentinvention, apparatus 70 may further include the use of imagingdiagnostic and feedback tool in conducting the directional impact suchas directional tightening. The imaging diagnostic tool may be conductedusing 2D or 3D pictures, received from any known capturing device (e.g.,imager 355), and image processing unit 350 as shown in FIG. 17A.

In some embodiments, controller 360 may be configured to cause thedelivery of RF energy by the RF delivery elements (e.g., element 1illustrated in FIGS. 1-12, 210, etc.) at predetermined RF parameters tocreate the elongated heated volume (e.g., volume 10). Controller 360 mayinclude any processing unit and storing device that is configured tostore and execute instructions according to any embodiment of theinvention. For example, the processing unit may include a centralprocessing unit (CPU), a chip or any suitable computing or computationaldevice. Controller 360 may also control the cooling unit (notillustrated).

Reference is now made to FIG. 17B which is a flowchart of a method ofnon-invasive directional tissue treatment according to some embodimentsof the invention. The treatment may be performed by any apparatusaccording to embodiments of the invention, for example, apparatus 70. Inbox 1710 the method may include setting a treatment protocol. Thetreatment protocol may include selecting the RF delivery parameters(e.g., current levels, plus duration, plus timing or the like),selecting a patch containing an array of RF delivery elements (e.g.,array 205) and/or selecting a sub-set of RF delivery elements (e.g., subset 150) to be operated and the timing for operating the sub-set.

In some embodiments, setting of a treatment protocol may includecapturing, by imager 355 (e.g., a capturing device), at least one imageof the area of the tissue to be treated and analyzing the at least oneimage, by the image processing unit (e.g., image processing unit 350),to determine the required treatment. The method may include capturing animage (e.g., by imager 355) of the treatment zone and processing theimage (e.g., by image processing unit 350 and controller 360) forreceiving comprehensive 2D or 3D model. The method may further includeconducting picture analysis and measuring tissue characteristics, eitherby measuring direct impedance of the tissue using the array or by othersensors (e.g., temperature sensors). The tissue characteristics mayinclude at least one of: tissue type, tissue thickness, tissuetemperature, and tissue impedance. The analyzed image(s) and measuredcharacteristics may be used for determining treatment protocol accordingto the required treatment.

For example, the image analysis and measured characteristics may be usedfor determination of lesion or ptosis level, for determination ofsuitability of the process, for selecting directional treatment andanalyzing expected results. The outcome of this process may includeimage based recommendation for the flexible plate or patch design andsize and placement orientation of the array and determination of RFtreatment parameters. The analysis may further predict an expectednumber of sessions and treatment algorithms per session and for theentire treatment. The analysis may be used in follow up process and toupdate the treatment parameters if needed. After the treatment theimaging analysis may be used to determine the overall impact.

An exemplary optical imaging diagnosis and feedback may be used forbreast ptosis or pseudoptosis using directional volumetric tighteningimpact. It may similarly be used for facial wrinkles or folds diagnosisand feedback, for underarm laxity treatment and the like. Thedirectional tightening may include further diagnostic tools such asimpedance monitoring to determine tissue temperature or tissue type andthickness.

In box 1720, the method may include attaching at least a portion of anarray of RF delivery elements, powered by an RF generator (e.g.,generator 310), to an area of the tissue to be treated. For example, apatch having a form of a bra (as illustrated and discussed with respectto FIG. 25) may be placed on a patient's chest for treating breastptosis. Alternatively, a randomly arranged array of elements, asillustrated in FIG. 12B, may be placed on the forehead of a patient forwrinkle removal. Other shapes and types of patches, flexible plates andapplicators may be used according to, for example, the requiredtreatment and the requirements of the patient.

In some embodiments, after attaching at least a portion of an array ofRF delivery elements, the setting or determining the treatment protocolmay further include: applying one or more pluses of RF energy, at levelof RF energy lower than the RF energy required to physiologically affectthe treated volume, and measuring impedance received at the one or morepulses. Based on the measured impedance, the controller (e.g.,controller 360) may be configured to determine tissue characteristics,such as, tissue type, tissue thickness and tissue temperature, anddetermine treatment protocol based the tissue characteristics. In someembodiments, the method may include setting the treatment protocol basedon information received from an imager (e.g., captured images) andmeasured tissue impedance. Controller 360 may be configured to processand analyze the image data received from the imager and tissue impedancemeasurements received from the RF generator to set the treatmentprotocol. In some embodiments, the method may include re-measuring theimpedance at at least one of: during the treatment and at the end of thetreatment.

In box 1730, the method may include activating the RF generator anddeactivating the RF generator by a controller (e.g., controller 360),based on the treatment protocol. For example, controller 360 mayactivate only a sub-set of RF delivery elements at a selected timingand/or apply different RF energy levels to different RF deliveryelements in the array or the sub-set of elements.

In some embodiments, the method may include selecting, by the controller(controller 360), two or more sub-groups of RF delivery elements fromthe array of RF delivery elements. In some embodiments, the method mayinclude applying a first set of RF delivery parameters to a first groupof RF delivery elements and applying a second set of RF deliveryparameters to a second group of RF delivery elements, wherein the firstset is different from the second set, wherein the first set is differentfrom the second set. In some embodiments, such method of applying the RFenergy may allow forming a decreased (or increased) amount of heatingalong a certain direction, as illustrated and discussed with respect toFIG. 14. In some embodiments, such method may include applying a thirdset of RF delivery parameters to a third group of RF delivery elements,wherein the heat per unit volume delivered when applying the second setof RF delivery parameters may be lower than the heat per unit volumedelivered by applying to element 1 the first set of RF deliveryparameters and the heat per unit volume delivered by applying the thirdset of RF delivery parameters may be lower than the heat per unit volumedelivered by applying the second set of RF delivery parameters.

In some embodiments, the method may further include re-measuring tissuecharacteristics at at least one of: during the treatment and the end ofthe treatment cycle and/or recapturing, by an imager, at least one imageof the area of the treated tissue at at least one of: during thetreatment and the end of the treatment.

In yet another exemplary embodiment of the current method and apparatus,the apparatus may also be designed to stimulate collagenesis, coagulatecollagen and tighten skin in areas such as, but not limited to, face forface lifting, wrinkles or folds reduction and skin rejuvenation, loosenunderarm for its tightening, and to breast area for breast remodeling.

In still another exemplary embodiment of the current method andapparatus, the apparatus may apply non-invasive types of cosmetictreatment to the body including combination of forms of energy such as,but not limited to RF energy combined with light (e.g., infra-red orvisual light) energy. Other modalities such as cooling elements may alsobe integrated thereto.

In another exemplary embodiment of the current method and apparatus thetissue attachable patch/flexible plate may be supplied by a rechargeableand/or disposable power and RF source.

Reference is now made to FIG. 19 which is an illustration of breasts anddesired impact of tightening and collagen synthesis per breast quartersaccording to some embodiments of the invention. Breasts 1010 and 1010 amay each be schematically divided into four quarters: upper innerquarter 1011, upper outer quarter 1012, that forms together upperanatomical pole 1001, lower inner quarter 1014 and lower outer quarter1013, that forms together lower anatomical pole 1002, with respect tobreast nipple 1015. During mastopexy procedure, excess skin may beremoved between lower inner 1014 and lower outer 1013 quarters of eachbreast 1010 and 1010 a. Post suturing, this superficial tissue reductionmay be equivalent to shrinkage along axis 1020. This may further resultin upwards push of the tissue of the lower and upper breast quarters indirection of axis 1021, which may be equivalent to impact caused byshrinkage or tightening of tissue along axes 1020 and 1021.

FIG. 20 is a schematic illustration of RF delivery elements arrayaccording to some embodiments of the invention for desired direction ofimpact for the upper and the lower breast 1010 and 1010 a poles 1002. RFdelivery elements 150 of the army 1050 to treat the lower breast polesare oriented to cause tightening along direction of axis 1020 and the RFdelivery elements 150 of the array 1051 to treat the upper breast polesare oriented to cause tightening along direction of axis 1021.

Reference is made to FIGS. 21A and 21B which are schematic illustrationsof electrode arrays and wiring for achieving a non-continuous tighteningimpact. This intends to prevent a linearly continuous tightening orstimulation impact on breast surface that may result in linear skinpatches at the phenotype level. FIG. 21A illustrates a mechanism todisrupt such linear effect while the electrodes of the positive 1068 andthe negative 1069 electrical branches may not be in a linear continuousdesign. Positively charged electrodes 1060, 1060 a, and 1060 b, mayelectrically communicate with negatively charged electrodes 1061 and1061 a. Negative electrodes 1061, 1061 a may not be positioned in lineardesign with positive electrodes 1060, 1060 a and 1060 b but may beshifted aside. Electrical paths formed 1062, 1062 a and their derivedheating impact may be diagonal, distorting and even preventing thelinear impact at phenotype level. FIG. 21B describes anothernon-limiting embodiment for preventing a linear patching. A linearpatching, according to some embodiments of the invention may include asituation where at the phenotype level lines of treated volumes are seenon the surface of the skin, following a treatment (e.g., heating) of thetissue In some embodiments, linear patching appearance may be blurredout by breaking the linearity or by breaking the continuity of a longlinear impacted zone.

According to some embodiments, several current loops may be formed andmay be used alternatively for at least one of RF branches 1077-1079 andelectrodes array 1077 a-1079 a related to RF branches 1077-1079. In thisnon-limiting embodiment, there may be a single negatively charged branch1079 and two positively charged branches 1077, 1078 that may bealternatively connected. For a given treatment, negatively chargedelectrode 1079 a of branch 1079, may be electrically connected witheither electrode 1077 a of positively charged branch 1077, or withelectrode 1078 a of positively charged branch 1078. Accordingly,electrical path and the electrical path impact in the tissue may be path797 for a certain treatment when branch 1077 is connected, or path 798for a given treatment when branch 1078 is connected, for instance duringanother (e.g. consecutive) treatment session when path 797 has alreadyhealed.

FIG. 22A is an illustration of a moving applicator for achieving desiredimpact of breast lifting (or any other tissue treatment) using treatmentin motion. Applicator 200 may include a grip 97 and cylindrically shapedtreatment roller portion 99. The treatment portion 99 may include anelectrically isolated non-conductive material, having an array ofelectrodes 90, 90 a, 90 b (each pair of negatively charged electrodes ormonopolar electrodes may be included in a single RF delivery element).In one embodiment the array of electrodes may be embedded within theroller's surface, whereas the inter-electrode wiring is in the innerpart (not seen) of the roller. In another embodiment a sheath withprinted electrodes or flexible printed circuit board with printedelectrodes may be attached or stick to the roller surface as areplaceable or disposable unit. Such a replaceable or disposableelectrode unit may enable the use of different electrodes configurations(e.g., different RF delivery elements as disclosed herein with respectto FIGS. 1-16), and spacing to be adapted to various treatmentparameters, for example, tissue thickness (different inter-electrodespacing) and treatment direction. Replaceable electrodes unit may haveanother advantage of sterilization. The replaceable unit may be cleanedand sterilized, may be replaced for another patient use, or may bereplaced when it becomes worn.

Each electrode pair or each monopolar electrode (e.g., RF deliveryelements) or sub set of electrode pairs or a sub set of monopolarelectrodes may be activated at a specific polarity at any instantaneoustime to follow a desired heat impact direction and depth per breastcondition, breast upper or lower quarters, and according to a specifictreatment protocol. The hand piece may be equipped with at least oneorientation sensor 98 that indicates its upward or downward facing. Thissensor may be embedded in the roller inner surface. In some embodiments,more than one sensor 98 and/or 98 a may be provided for example, atorthogonal positions to ascertain the roller's angular orientation.Alternatively, rotation or angular encoder 96 may be used instead of oneor two of the orientation sensors, or in addition to it. In anotherconfiguration the orientation sensor may be attached to the hand-piecenon-rotating component 98 b. The grip may contain RF driver 93, systemcontroller 94 and power supply or batteries 95. To ensure that everytreated area may receive the desired energy planned to achieve thedesired tissue heat profile, the device may include a motion sensor 96and a speed detector together with encoder. This assembly may enable RFpulses delivery per speed of movement. The device may also includesurface cooler to ensure comfort use. The cooler may be in form ofThermo-Electric-Chiller or air cooling element.

FIG. 22B is an illustration of a moving applicator in a stamping modefor achieving desired impact of breast lifting or any other tissuetreatment. Applicator 200 may be included in a hand-piece, which mayinclude of a grip 97 and shaped treatment surface portion 99. Thetreatment surface portion 99 may be composed of electrically isolatednon-conductive material, having array of electrodes 90, 90 a, 90 b. Theapplicator components and paired-electrode orientation concepts may besimilar to those of the roller configuration presented in FIG. 22A withthe necessary adjustments. Treatment according to this embodiment may becarried out in a stamping mode, as illustrated in FIG. 22 C. Tissue 400may be treated by moving applicator 200 from one stamping position 410to an adjacent stamping position 420. At each applicator position (e.g.,410, 420) on tissue 400 (‘stamping’) an area similar to the applicatortreatment surface may be treated to form elongated heated volumes (e.g.,volumes 10) of predetermined orientation. Treatment may be conducted byput-and-stamp area 410 then moving the applicator to adjacent area 420for an additional put-and-stamp and so on until covering the entiretreated tissue 400 surface in the predetermined orientation. Fine tuningof the orientation of the elongated treated volumes at each applicatorpositions may be done by rotating treatment surface portion 99 once theapplicator is positioned on the surface before activating the RF, basedon orientation sensor 98. The treatment surface portion may bedisposable.

In some embodiments, applicator 200 and/or apparatus 70 may furtherinclude a motion sensor for monitoring the motion of the apparatusand/or applicator with respect to the treated tissue.

FIG. 23A is an illustration of a one non-limiting embodiment of part ofthe electrodes array where the electrodes' array is divided into 3interlaced sub arrays each can be connected to an electrical polarity.FIG. 23B is a schematic of the same array presented in FIG. 23A whereone array 1083 is electrically disconnected. The 2 remaining activatedsub arrays may be connected to have a lateral horizontal electricalcurrent flow 1080 and its derived heat impact between positive 1082 andnegative 1081 electrodes (e.g., included in RF delivery elements), inthe tissue.

This connection of activation of electrical branches 1 and 2 may be donewhen treating the lower quarters of the breast. FIG. 23C is anotherschematic of the array presented in FIG. 23A where the sub arrays ofelectrical branches 1 and 3, and related positively and negativelycharged electrodes may be connected, while one electrical branch 1085may be disconnected. The activated sub arrays of the positively chargedelectrodes 1086 and the negatively charged electrodes 1087 may beconnected to have a vertical electrical current flow 1088 and itsderived heat impact in the tissue. Such electrical connection may beactivated when treating the upper quarters of the breast.

The activation of the required electrodes sub arrays may be done eitherelectronically or mechanically. For the roller applicator, theactivation of the required electrodes sub arrays may be based on theorientation of the roller's surface being in contact with the skin. Ifthe roller's surface that being active with the skin is facing down,then at this moment the upper breast quarter may be treated. If theroller's surface being in contact with the skin is facing up, then atthis moment the lower breast quarter is being treated. For orientationsthat might be ambiguous on whether upper or lower quarter may be incontact with the roller's surface. An algorithm based on theorientations history may be used to remove the ambiguity.

In some embodiments, the penetration depth of the RF current may bedependent on known factors such as distance between electrodes or RFfrequency. Therefore, at a primary level, the inter-electrode distancemay be set to control the depth of treatment. In some embodiments, aneffective penetration depth of the RF current may be the depth where asignificant percentage of the RF energy can efficiently impact (e.g.,heat) the tissue. An exemplary calculation of the effective depth beingaffected by RF current may result in that the effective depth may behalf the distance between electrode's pair or the dimension of themonopolar electrode. For example, to confine the impacting heat to adepth of 2 mm the distance between adjacent opposite polarities RFelectrodes should be 4 mm. This calculation may allow targeting theheating of tissue to desired portions such as the dermis and fasciadepth levels, and to avoid undesired heating of deeper fat and glandularportions of the breast. For each inter electrode distance RF frequencymay be tuned to further control the effective depth.

According to some embodiments, the distance between electrodes or thedimension or the electrodes may be adapted to the breast or othertreated anatomies skin thickness. RF frequency tuning may be conductedelectrically, e.g. by RF generator 310 (in FIG. 17A).

According to some embodiments, pretreatment measurement of the skinthickness may be done based on impedance difference between tissues'types.

In some embodiments, the adaptation of electrode spacing to the skinthickness may be done in various ways. FIG. 24A is an illustration of anelectrode array that is constructed with very short spacing (d) betweenadjacent electrodes. Short distance spacing may be defined as spacingshorter than the heat dissipation distance in a tissue per the treatmenttime. This small distance may be designed to limit the treatment depthwhen treating the minimum breast skin thickness. For example, in orderto achieve this depth limit RF generator may activate for each electroderow (e.g., rows A, B. C. D) every adjacent electrode in alternatingpolarity, e.g., every even electrode in one polarity and every oddelectrode with the other polarity. For thicker skin areas, longerdistance electrodes may be paired. For example, only odd electrodes maybe used where each (1+4i (i is an integer)) electrode in a row may beconnected to one polarity and each (3+4i) electrode in a row may beconnected to the other polarity. Other combinations of pairingelectrodes may be used.

In some embodiments, the pairing may be done before treatment and may bedifferent for different anatomies and different treatment protocols, forexample, different pairing may be used for the upper and lower breast'sanatomic poles. In other embodiments, the pairing may be donedynamically during treatment to be adapted to local skin thickness.

FIG. 24B is an illustration of another embodiment disclosing a pluralityof electrodes arrays (1, 2, 3 and 4) each having a first inter-electrodedistance D, arrays 1, 2, 3 and 4 may be interlaced in each other so thata second distance (d) between one electrode of a first array and anotherproximal electrode of a second proximal array may shorter thaninter-electrode distance D of each of arrays 1, 2, 3 and 4. Electrodes'pairing may be done based on skin thickness. One can activate array “1”at one polarity and array “2” at another polarity without connectingarrays 3 and 4 to achieve active pairs distance of “2 d”, or Arrays “1”and “2” can be connected to the same polarity and connecting arrays “3”and “4” to the opposite polarity to achieve active pairs distance “d”.

In another embodiment, adaptation to skin thickness may be done byattaching or sticking a sheath or flexible printed circuit board withthe suitable electrode size and spacing to applicator (200 in FIGS. 22Aand 22B) surface.

In another embodiment, a roller with embedded electrodes may be includedin a replaceable unit and may be replaced by another unit havingdifferent electrodes spacing and size according to the treatmentrequirements.

FIG. 25 is a schematic illustration of wearable applicator, designed asa bra, for achieving a desired impact according to some embodiments ofthe invention.

In FIG. 25 electrodes are shown only in a left bra 1250 (for ease ofexplanation) but may be implemented in the right bra in a similarmanner.

According to some embodiments, the RF electrodes covering the lowerbreast quarters may be positioned in such a way to create elongated heatvolumes aligned with their long dimension in the lateral generaldirection. This may result in skin tightening of the lower breastquarters in the overall direction of arrow 1220 and therefore liftingthe breast mass in the overall direction of arrow 1221.

According to some embodiments, the RF electrodes covering the upperbreast quarters of the breast may be positioned in such a way to createelongated heat volumes aligned with their long dimension in the verticalgeneral direction. This may result in tightening of the upper breastquarters in the overall direction of arrow 1221 and therefore furtherlifting the breast mass and the nipple and areola. The nipples area1215, lacking underneath fat support, may not be wired.

The design of bra-applicator 1250 may ensure sufficient contact betweenthe electrodes and the skin for the delivery of a required amount of RFenergy to the breast tissue.

In some embodiments, bra 1250 may be manufactured in several sizes tofit different breast sizes.

In one embodiment bra 1250 may be made of silicone gel with embeddedelectrodes that stick to the breast skin. According to some embodiments,this bra may cover the whole breast surface that is to be treated.

In another embodiment bra 1250 may include at least an outer layer madefrom any textile material and at least an inner layer made from siliconegel or other material that ensures contact with the breast skin.According to some embodiments, the electrodes may be embedded in theinner layer or any other additional layer. Electrical coupling with theskin may be ensured using gel, or different coupling media.

In yet another embodiment the electrodes may be printed on at least onesheath or on at least one flexible printed circuit board that may beattached or stuck to the inner bra surface and or to the breast skin.

Electrodes' sheath, according to some embodiments, may be replaceable,and/or may be configurable to support different breast sizes, ptosislevels or skin thickness.

According to some embodiments, the electrode array may also be adisposable unit that may be replaced, for example, every new treatmentsession while the other product components that may be more expensiveand are not with direct contact with the body may be reused. Theelectrode sheath may be electrically connected to the RF generator (310in FIG. 17A).

Since batteries may have limited electrical current supply, the systemcontroller may activate subsets of electrodes sequentially untilcovering the whole surface to be treated per the treatment protocol.This sequential operation may ensure operation within the batteriesdrive current limits. Unless explicitly stated, the method embodimentsdescribed herein are not constrained to a particular order in time orchronological sequence. Additionally, some of the described methodelements may be skipped, or they may be repeated, during a sequence ofoperations of a method.

While certain features of the invention have been illustrated anddescribed herein, many modifications, substitutions, changes, andequivalents will now occur to those of ordinary skill in the art. It is,therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the true spiritof the invention.

Various embodiments have been presented. Each of these embodiments mayof course include features from other embodiments presented, andembodiments not specifically described may include various featuresdescribed herein.

What is claimed is:
 1. An apparatus for non-invasive directional tissuetreatment comprising: a two-dimensional array of energy deliveryelements placed in a predetermined order defining a tissue treatmentarea, said array having a first direction and a second directiontransverse to the first direction; a power source; and a controller,wherein each of the energy delivery elements is configured to heat aportion of tissue volume within the tissue treatment area and each saidenergy delivery element has a dimension in the first direction and inthe second direction; wherein the predetermined order of positioningeach energy delivery element is such that a density of treatment energydelivery elements dimensions in the array is higher in the firstdirection than the density of the energy delivery element dimensions inthe second direction; and wherein, applying energy to thetwo-dimensional array is configured to heat tissue in at least oneportion of tissue treatment volume; and wherein tissue tightening ishigher in the first direction than in the second direction of thetwo-dimensional array.
 2. The apparatus according to claim 1, whereinthe energy delivery elements are light, microwave or ultrasoundelements.
 3. The apparatus according to claim 1, wherein each deliveryelement is elongated in the first direction, configured to heat anelongated tissue volume in the tissue treatment area.
 4. The apparatusaccording to claim 1, wherein each energy delivery element comprisesmultiple energy delivery sub-elements adapted to heat at least onetissue treatment volume, and wherein said multiple energy deliverysub-elements together define said treatment volume dimensions in saidfirst direction and said second direction.
 5. The apparatus according toclaim 1, wherein the two-dimensional array comprises at least a firstgroup of energy delivery elements configured to heat a first group ofvolume portions of tissue, said energy delivery elements dimensions havea first density in the first direction.
 6. The apparatus according toclaim 5, wherein the two-dimensional array comprises at least a secondgroup of energy delivery elements configured to heat a second group ofvolume portions of tissue, said second group of energy delivery elementsdimension having a second density in the first direction which isdifferent from the first density of tissue treatment volume dimensionsof the first group of energy delivery elements in the first direction.7. The apparatus according to claim 1, wherein the energy deliveryelements in the array are arranged in rows and columns.
 8. The apparatusaccording to claim 1, wherein a first distance between first and secondenergy delivery elements in the two-dimensional array is different froma second distance between second and third energy delivery elements, inthe two-dimensional array.
 9. The apparatus according to claim 1,wherein the two-dimensional array comprises at least a first group ofenergy delivery elements located at a first area and a second group ofenergy delivery elements located at a second area, different from saidfirst area, and wherein a density of energy delivery element dimensionsin a first direction in the first area is different from a density ofenergy delivery element dimensions in the second area.
 10. The apparatusaccording to claim 1, further comprising an applicator in a form of apatch, wherein the patch is configured to suit an anatomy of thetreatment area, and wherein the two-dimensional array is configuredaccording to the anatomy and a predetermined tightening direction. 11.The apparatus according to claim 9, wherein the patch is in a braconfiguration, and wherein the two-dimensional array comprises at leasttwo sub arrays, wherein the first sub array is configured to heat afirst group of elongated volume portions of tissue having a firstorientation and wherein the second sub array is configured to heat asecond group of elongated volume portions of tissue having a secondorientation different from the first orientation, wherein, the firstorientation is configured to cause tightening of a lower breast pole ina lateral direction and the second orientation is configured to causetightening and lifting of an upper breast pole in a vertical direction.12. The apparatus according to claim 1, further comprising a computingdevice in active communication with the controller, the computing devicecomprising: an imager, configured to capture one or more images of anarea of the tissue to be treated; at least one input device configuredto receive instructions from a user; and a processor, configured toreceive the images captured by the imager and the instructions receivedvia the input device and to create a treatment protocol.
 13. Theapparatus according to claim 11, wherein the processor is furtherconfigured to analyze the received images to determine requiredtreatment parameters, and to create a 3D model of the tissue treatmentarea.
 14. A method of non-invasive directional tissue tighteningcomprising: setting a treatment protocol; attaching a two-dimensionalarray of energy delivery elements to a tissue treatment area of asubject, said two-dimensional array having a first direction and asecond direction transverse to the first direction; wherein each energydelivery element having dimensions in said first and second directions;supplying power to said energy delivery elements from a power source toheat at least one volume portion of tissue in the said treatment area;with the controller, activating and deactivating the energy deliveryelements in accordance with the treatment protocol, wherein each energydelivery element is positioned such that the density of the energydelivery elements dimensions in the array is higher in the firstdirection than the energy delivery elements dimensions in the seconddirection; and wherein the treatment protocol and the position of theenergy delivery elements are configured so that tissue tightening ishigher in the first direction than in the second direction.
 15. Themethod according to claim 14, wherein the setting of the treatmentprotocol comprises: capturing, by an imager, at least one image of thetissue treatment area; analyzing the at least one image to determinerequired treatment; measuring at least one tissue characteristics; anddetermining the treatment protocol based on the required treatment, andthe at least one tissue characteristic.
 16. The method according toclaim 14, wherein the tissue characteristics is selected from the groupconsisting of: tissue type, tissue thickness, tissue temperature, andtissue impedance.
 17. The method according to claim 14, furthercomprising: selecting, by the controller, two or more sub-groups ofenergy delivery elements in the two-dimensional array; applying a firstset of energy delivery parameters to a first sub-group of energydelivery elements; and applying a second set of energy deliveryparameters to a second group of delivery elements, wherein the first setof energy delivery parameters is different from the second set of energydelivery parameters.
 18. The method of claim 14, wherein said energydelivery elements are adapted to deliver light, microwave, ultrasound,mechanical, or heat energy to one or more tissue treatment volumes.